The "Reaper" vaccine received a special evaluation agreement from the US FDA, which is expected to extend the recurrence-free survival period.

January 16, 2022 / eMedClub PR News/--Recently, Polynoma LLC, a biopharmaceutical company focused on immuno-oncology, announced that it has entered into a special evaluation agreement (SPA) with the U.
S.
FDA for a cancer vaccine for the treatment of melanoma The pivotal Phase III clinical study of seviprotimut-L reached an agreement for the adjuvant treatment of stage IIB or IIC melanoma patients aged 60 years and older after definitive surgical resection to improve recurrence-free survival (RFS)
.

In June 2020, Seviprotimut-L was granted Fast Track designation by the US FDA
.

Melanoma is a malignant tumor derived from melanocytes and is the most malignant tumor in skin tumors
.

In 2021, more than 100,000 new melanoma patients will be diagnosed in the United States alone
.

Worldwide, approximately 350,000 people with melanoma die each year
.

As melanoma grows, cancer cells penetrate the skin and mucous membranes, eventually reaching blood vessels or lymphatic channels, and rapidly spreading throughout the body and major organs
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Once metastasis occurs, the 5-year survival rate of patients is only 4.
6%
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Due to the high mortality rate, high metastasis rate and difficult treatment, melanoma is known as the "king of cancers"
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seviprotimut-L is an allogeneic, multivalent, partially purified exfoliated melanoma antigen vaccine containing soluble antigen exfoliated from three human melanoma cell lines, which can be easily prepared for large-scale patient use crowd
.

seviprotimut-L acts by stimulating humoral and cellular immune responses: melanoma-associated antigens (MAAs) are taken up by antigen-presenting cells (e.
g.
, dendritic cells), which then activate antigen-specific cytotoxic T lymphocytes (CTLs), which produce antibodies against MAAs of antibodies
.

These CTLs and antibodies then recognize and act on tumor cells that express MAAs on their surface, causing them to die
.

▲Image source: Polynoma's official website Recently, Polynoma's research paper on the final analysis results of the B1 data of the Melanoma Antigen Vaccine Immunotherapy Study (MAVIS) was published in the Journal for ImmunoTherapy of Cancer (JITC), with the title of " Multicenter, double-blind, placebo-controlled trial of seviprotimut-L polyvalent melanoma vaccine in patients with post-resection melanoma at high risk of recurrence”
.

MAVIS is a multicenter, double-blind, placebo-controlled, adaptive phase III trial to evaluate the safety and efficacy of seviprotimut-L with the primary endpoint of melanoma patients at high risk of recurrence after definitive surgical resection of recurrence-free survival (RFS) and overall survival (OS)
.

Trial results showed significantly improved clinical outcomes in patients with stage IIB/IIC melanoma under 60 years of age who received seviprotimut-L (median follow-up 45.
8 months (3.
8 years)) compared to patients who received placebo , RFS and OS tended to prolong, and the risk of disease recurrence or death was reduced by 68%
.

In addition, patients under 60 years of age with stage IIB/IIC primary melanoma benefited from seviprotimut-L
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In terms of safety, seviprotimut-L was well tolerated, with adverse events (AEs) similar to those in the placebo-treated cohort, and no immune-mediated AEs or other serious treatment-related AEs were observed
.

▲Image source: Craig L.
Slingluff, Ph.
D.
, the lead author of the research paper on the official website of Polynoma, said: "seviprotimut-L has the advantage of very low toxicity, and no serious immune-related adverse events were observed after use, compared with the placebo-treated cohort.
In contrast, there was no significant increase in toxicity
.

If evaluation of seviprotimut-L clearly demonstrates clinical benefit in patients with stage IIB/IIC melanoma, especially those aged 60 years and younger, then seviprotimut-L will is a valuable option for these patients
.

" "The SPA agreement with the U.
S.
FDA on our planned pivotal trial provides important guidance on the regulatory pathway to approval of seviprotimut-L as an adjuvant therapy for stage IIB/IIC melanoma
.

" Chairman and Chairman of Polynoma CK Life Sciences vice president and chief executive officer Yu Lei said, "we believe the results of this trial will support seviprotimut-L as the preferred treatment of melanoma patients younger limitations
.
"
superiority cancer vaccine is part of a cancer vaccine in cancer immunotherapy One of the newest forms of treatment, cancer vaccines generally do not have serious side effects compared to chemotherapy and radiation.
Unlike chemotherapy and radiation, which directly kill tumor cells and normal rapidly dividing cells in the body, cancer vaccines and other immunotherapies are delivered through Stimulating the body's immune system to exert its anti-cancer effect only targets tumor cells and reduces the occurrence of side effects
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Given these characteristics, cancer vaccines offer cancer patients a more targeted, gentler approach to cancer treatment that is far less harmful to the body and offers the hope of a better quality of life for patients
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In recent years, with the continuous in-depth research of cancer vaccines, many gratifying results have been achieved in the industry
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➤ In November 2021, Northwest Biotherapeutics announced the completion of a $15 million financing to accelerate clinical studies of the company's DCVax-L in glioblastoma multiforme (GBM)
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DCVax-L is a personalized DC tumor vaccine that uses the patient's own DC to help activate the immune system to fight cancer
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Recommended reading: DC Vaccine Receives Another High Financing to Advance Clinical Research to Treat Malignant Brain TumorsYimai Meng broke the news ➤ In November 2021, BioNTech announced that the US FDA granted its mRNA cancer vaccine BNT111 Fast Track designation
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BNT111 is an intravenously administered therapeutic mRNA cancer vaccine encoding 4 tumor-associated antigens (TAAs), NY-ESO-1, MAGE-A3, tyrosinase and TPTE, in over 90% of melanomas One of these 4 TAAs is expressed in patients
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The vaccine candidate is currently undergoing a Phase 2 clinical trial evaluating its efficacy and safety in patients with PD-1 inhibitor-refractory/relapsed and unresectable stage III or IV melanoma
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Recommended Reading: BioNTech's mRNA Cancer Vaccine Receives US FDA Fast Track Designation for the Treatment of Advanced MelanomaMimiVac LLC announced in November 2021 that SurVaxM has been approved by the US FDA in Phase 2b trials, and the evaluation is in Effectiveness of newly diagnosed glioblastoma
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SurVaxM is a peptide-mimicking tumor immune vaccine that can target a cell survival protein called Survivin, has a unique cell- and antibody-mediated anti-tumor response, and can simultaneously trigger T-cell and B-cell immunity and antibody-directed survivin pathway inhibition The dual mechanism of action stimulates the immune system to kill survivin-containing tumor cells, controls tumor growth and prevents or delays tumor recurrence
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Recommended reading: FDA approves 2b clinical trial of MimiVac peptide-mimicking tumor vaccine for glioblastoma Hospital, BWH) and Broad Institute researchers published a new study in the journal Nature Medicine that four years after melanoma patients were treated with the personalized cancer vaccine NeoVax, the vaccine-elicited immune response maintained a strong and effective cancer control effect
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NeoVax is a long-peptide vaccine against up to 20 personalized neoantigens in a patient that works by targeting specific proteins on these tumor cells
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Recommended reading: Nature sub-issue: Not only 4 years of potent and durable cancer control, but also the anti-tumor activity induced by this personalized cancer vaccine has been further expandedYimai Meng broke the news.
Conclusion A large number of studies have confirmed the feasibility of cancer vaccines.
With the follow-up of more clinical research experiments, cancer vaccines will play an important role in cancer treatment
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References: 1.
https:// -clinical-study-of-seviprotimut-la-melanoma-cancer-vaccine/Disclaimer: The content in this article is only for exploring the frontiers of biomedicine and does not constitute any medical guidance.
Please go to a regular hospital for treatment if necessary
.